SIST EN ISO 21549-3:2014

Health informatics - Patient healthcard data - Part 3: Limited clinical data (ISO 21549-3:2014)

EN ISO 21549-3 is applicable to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. This part of ISO 21549 describes and defines the limited clinical data objects used in or referenced by patient healthcards using UML, plain text and abstract syntax notation (ASN.1).” This part of ISO 21549 specifies the basic structure of the data contained within the data object limited clinical data, but does not specify or mandate particular data sets for storage on devices. In particular the data contained within the data objects in Limited clinical data are intended to aid the delivery of emergency care, whilst are by themselves neither intended, nor fit for purpose for the total of information provision for the delivery of emergency care. The detailed functions and mechanisms of the following services are not within the scope of this part of ISO 21549, (although its structures can accommodate suitable data objects elsewhere specified): - the encoding of free text data; - security functions and related services which are likely to be specified by users for data cards depending on their specific application, for example: confidentiality protection, data integrity protection, and authentication of persons and devices related to these functions; - access control services which may depend on active use of some data card classes such as microprocessor cards; - the initialisation and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this part of ISO 21549). The following topics are therefore beyond the scope of this part of ISO 21549: - physical or logical solutions for the practical functioning of particular types of data cards; - how the message is processed further "downstream" of the interface between two systems; - the form which data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.

Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 3: Kerndatensatz der klinischen Daten (ISO 21549-3:2014)

Informatique de santé - Données relatives aux cartes de santé des patients - Partie 3: Données cliniques limitées (ISO 21549-3:2014)

L'ISO 21549-3:2014 s'applique aux situations dans lesquelles les données cliniques limitées sont enregistrées sur ou transportées par des cartes de données des services de santé des patients conformes aux dimensions physiques des cartes ID-1 définies dans l'ISO/CEI 7810.
L'ISO 21549-3:2014 décrit et définit les objets de données cliniques limitées utilisés dans le cadre de ou référencés par les cartes de données de santé des patients au moyen du langage UML, de texte en clair et de la notation de syntaxe abstraite (ASN.1).
L'ISO 21549-3:2014 spécifie la structure de base des données contenues dans les données cliniques limitées de l'objet de données mais ne spécifie pas ou ne rend pas obligatoires des ensembles de données particuliers destinés à être stockés sur des dispositifs.

Zdravstvena informatika - Podatki o pacientu na zdravstveni kartici - 3. del: Omejeni klinični podatki (ISO 21549-3:2014)

EN ISO 21549-3 se uporablja za situacije, kjer se takšni podatki zapišejo na zdravstvene kartice pacientov, skladne s fizičnimi merami kartic ID-1, kot jih določa ISO/IEC 7810, oziroma se podatki prenašajo na tak način. Ta del standarda ISO 21549 opisuje in opredeljuje predmete omejenih kliničnih podatkov, ki se uporabljajo na podatkovnih karticah pacientov ali so na njih in uporabljajo označevanje UML, navadno besedilo ali abstraktno skladnjo (ASN.1). Ta del standarda ISO 21549 navaja osnovne strukture podatkov, ki so vsebovani v predmetu omejenih kliničnih podatkov, vendar ne navaja ali določa specifičnih naborov podatkov za shranjevanje v napravah. Zlasti podatki, ki so vsebovani v podatkovnih predmetih omejenih kliničnih podatkov, so namenjeni za pomoč pri zagotavljanju nujne medicinske oskrbe, vendar po sebi niso namenjeni niti primerni za zagotavljanje popolne informacije pri zagotavljanju nujne medicinske oskrbe. Podrobno delovanje in mehanizmi naslednjih storitev niso del obsega tega dela standarda ISO 21549 (čeprav njihove strukture omogočajo prilagajanje primernih podatkovnih predmetov, navedenih drugje): – kodiranje podatkov prostega besedila; – varnostne funkcije in povezane storitve, za katere obstaja verjetnost, da jih bodo uporabniki navedli za podatkovne kartice, glede na specifično uporabo, npr.: varovanje zaupnosti, varovanje integritete podatkov in preverjanje pristnosti oseb in naprav, povezanih s temi nalogami; – storitve nadzora do dostopa, ki so lahko odvisne od aktivne uporabe nekaterih razredov podatkovnih kartic, kot so mikroprocesorske kartice; – postopek inicializacije in izdaje (s katerim se začne življenjska doba uporabe posamezne podatkovne kartice in s katerim se podatkovna kartica pripravi za podatke, ki ji bodo posledično sporočene v skladu s tem delom standarda ISO 21549). Naslednje teme ne spadajo na področje uporabe tega dela standarda ISO 21549: – fizične in logične storitve za praktično delovanje določenih vrst podatkovnih kartic; – način nadaljnje obdelave sporočila pod vmesnikom med dvema sistemoma; – oblika, v kateri so podatki za uporabo zunaj podatkovne kartice, ali način, kako so ti podatki vidno predstavljeni na podatkovni kartici ali drugje.

General Information

• Status: Published
• Public Enquiry End Date: 30-Sep-2012
• Publication Date: 11-Jun-2014
• ICS: 35.240.15 - Identification cards. Chip cards. Biometrics
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 03-Mar-2014
• Due Date: 08-May-2014
• Completion Date: 12-Jun-2014
• Mandate: M/255 - Standardization mandate to CEN, CENELEC and ETSI in the field of health care informatics
• Ref Project: EN ISO 21549-3:2014 - Health informatics - Patient healthcard data -- Part 3: Limited clinical data (ISO 21549-3:2014)

Relations

• Replaces: SIST EN ISO 21549-3:2004 - Health informatics - Patient healthcard data - Part 3: Limited clinical data (ISO 21549-3:2004)
• Effective Date: 01-Jul-2014
• Replaces: SIST EN ISO 21549-3:2004 - Health informatics - Patient healthcard data - Part 3: Limited clinical data (ISO 21549-3:2004)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21549-3:2014
01-julij-2014
1DGRPHãþD
SIST EN ISO 21549-3:2004
=GUDYVWYHQDLQIRUPDWLND3RGDWNLRSDFLHQWXQD]GUDYVWYHQLNDUWLFLGHO
2PHMHQLNOLQLþQLSRGDWNL,62
Health informatics - Patient healthcard data - Part 3: Limited clinical data (ISO 21549-
3:2014)
Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 3:
Kerndatensatz der klinischen Daten (ISO 21549-3:2014)
Informatique de santé - Données relatives aux cartes de santé des patients - Partie 3:
Données cliniques limitées (ISO 21549-3:2014)
Ta slovenski standard je istoveten z: EN ISO 21549-3:2014
ICS:
35.240.15 Identifikacijske kartice in Identification cards and
sorodne naprave related devices
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 21549-3:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 21549-3:2014

---------------------- Page: 2 ----------------------

SIST EN ISO 21549-3:2014

EUROPEAN STANDARD
EN ISO 21549-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2014
ICS 35.240.80 Supersedes EN ISO 21549-3:2004
English Version
Health informatics - Patient healthcard data -- Part 3: Limited
clinical data (ISO 21549-3:2014)
Informatique de santé - Données relatives aux cartes de Medizinische Informatik - Patientendaten auf Karten im
santé des patients - Partie 3: Données cliniques limitées Gesundheitswesen - Teil 3: Kerndatensatz der klinischen
(ISO 21549-3:2014) Daten (ISO 21549-3:2014)
This European Standard was approved by CEN on 13 December 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21549-3:2014 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 21549-3:2014
EN ISO 21549-3:2014 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 21549-3:2014
EN ISO 21549-3:2014 (E)
Foreword
This document (EN ISO 21549-3:2014) has been prepared by Technical Committee ISO/TC 215 “Health
informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by August 2014, and conflicting national standards shall be withdrawn at
the latest by August 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21549-3:2004.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21549-3:2014 has been approved by CEN as EN ISO 21549-3:2014 without any modification.


3

---------------------- Page: 5 ----------------------

SIST EN ISO 21549-3:2014

---------------------- Page: 6 ----------------------

SIST EN ISO 21549-3:2014
INTERNATIONAL ISO
STANDARD 21549-3
Second edition
2014-02-15
Health informatics — Patient
healthcard data —
Part 3:
Limited clinical data
Informatique de santé — Données relatives aux cartes de santé des
patients —
Partie 3: Données cliniques limitées
Reference number
ISO 21549-3:2014(E)
©
ISO 2014

---------------------- Page: 7 ----------------------

SIST EN ISO 21549-3:2014
ISO 21549-3:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 21549-3:2014
ISO 21549-3:2014(E)

Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 2
5 Basic data object model for a healthcare data card - Patient healthcard data
object structure . 2
6 Basic data objects for referencing . 3
6.1 Overview . 3
6.2 Coded data . 3
6.3 Device and data security attributes . 3
6.4 Accessory attributes . 3
7 Limited clinical data . 4
7.1 General . 4
7.2 The limited emergency data set . 4
7.3 Immunization details. 5
7.4 Blood grouping and transfusion record . 6
7.5 The extended emergency data set . 7
Annex A (normative) ASN.1 Data definitions. 9
Bibliography .11
© ISO 2014 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 21549-3:2014
ISO 21549-3:2014(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO 21549-3:2004), which has undergone a
minor revision. The following changes have been made.
— Foreword: mention of CEN collaboration is removed.
— Scope:. first line is reworded.
— Normative references: references that are not cited normatively are moved to the Bibliography.
— Clause 5: paragraph after Figure 1 is reworded.
— Subclause 7.1: last sentence before Figure 2 is reworded.
— Clauses 6, and 7: the figures are renumbered sequentially and references to figures and tables are
added.
— Clause 7: the class ExtendedEmergencyData is moved from Part 4 to Part 3.
— Bibliography: dates from the references are removed where not applicable.
ISO 21549 consists of the following parts, under the general title Health informatics — Patient healthcard
data:
— Part 1: General structure
— Part 2: Common objects
— Part 3: Limited clinical data
— Part 4: Extended clinical data
— Part 5: Identification data
iv © ISO 2014 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 21549-3:2014
ISO 21549-3:2014(E)

— Part 6: Administrative data
— Part 7: Medication data
— Part 8: Links
© ISO 2014 – All rights reserved v

---------------------- Page: 11 ----------------------

SIST EN ISO 21549-3:2014
ISO 21549-3:2014(E)

Introduction
With a more mobile population, greater healthcare delivery in the community and at patients’ homes,
together with a growing demand for improved quality of ambulatory care, portable information
systems and stores have increasingly been developed and used. Such devices are used for tasks ranging
from identification, through portable medical record files, and on to patient-transportable monitoring
systems.
The functions of such devices are to carry and to transmit person-identifiable information between
themselves and other systems; therefore, during their operational lifetime they may share information
with many technologically different systems which differ greatly in their functions and capabilities.
Healthcare administration increasingly relies upon similar automated identification systems. For
instance prescriptions may be automated and data exchange carried out at a number of sites using
patient transportable computer readable devices. Healthcare insurers and providers are increasingly
involved in cross-region care, where reimbursement may require automated data exchange between
dissimilar healthcare systems.
The advent of remotely accessible databases and support systems has led to the development and use of
“Healthcare Person” identification devices that are also able to perform security functions and transmit
digital signatures to remote systems via networks.
With the growing use of data cards for practical everyday healthcare delivery, the need has arisen for a
standardized data format for interchange.
The person-related data carried by a data card can be categorized in three broad types: identification
(of the device itself and the individual to whom the data it caries relates), administrative and clinical.
It is important to realize that a given healthcare data card “de facto” has to contain device data and
identification data and may in addition contain administrative, clinical, prescription and linkage data.
Device data are defined to include:
— identification of the device itself;
— identification of the functions and functioning capabilities of the device.
Identification data may include:
— unique identification of the device holder or of all other persons to whom the data carried by the
device are related.
Administrative data may include:
— complementary person(s) related data;
— identification of the funding of healthcare, whether public or private, and their relationships i.e.
insurer(s), contract(s) and policy(ies) or types of benefits ;
— other data (distinguishable from clinical data) that are necessary for the purpose of healthcare
delivery.
Clinical data may include:
— items that provide information about health and health events;
— their appraisal and labelling by a healthcare provider (HCP);
— related actions planned requested or performed.
Because a data card essentially provides specific answers to definite queries while having at the same
time a need to optimize the use of memory by avoiding redundancies, “high level” Object Modelling
Technique (OMT) has been applied with respect to the definition of healthcare data card data structures.
vi © ISO 2014 – All rights reserved

---------------------- Page: 12 ----------------------

SIST EN ISO 21549-3:2014
ISO 21549-3:2014(E)

This part of ISO 21549 describes and defines the Limited Clinical Data objects used within or referenced
by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
This part of ISO 21549 does not describe and define the common objects defined within ISO 21549-2
even though they are referenced and utilized within this part of ISO 21549.
© ISO 2014 – All rights reserved vii

---------------------- Page: 13 ----------------------

SIST EN ISO 21549-3:2014

---------------------- Page: 14 ----------------------

SIST EN ISO 21549-3:2014
INTERNATIONAL STANDARD ISO 21549-3:2014(E)
Health informatics — Patient healthcard data —
Part 3:
Limited clinical data
1 Scope
This part of ISO 21549 is applicable to situations in which limited clinical data are recorded on or
transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by
ISO/IEC 7810.
This part of ISO 21549 describes and defines the limited clinical data objects used in or referenced by
patient healthcards using UML, plain text and abstract syntax notation (ASN.1).
This part of ISO 21549 specifies the basic structure of the data contained within the data object limited
clinical data, but does not specify or mandate particular data sets for storage on devices. In particular
the data contained within the data objects in limited clinical data are intended to aid the delivery
of emergency care, while being by themselves neither intended, nor fit for purpose, for the total of
information provision for the delivery of emergency care.
The detailed functions and mechanisms of the following services are not within the scope of this part of
ISO 21549, (although its structures can accommodate suitable data objects elsewhere specified):
— the encoding of free text data;
— security functions and related services which are likely to be specified by users for data cards
depending on their specific application, for example: confidentiality protection, data integrity
protection, and authentication of persons and devices related to these functions;
— access control services which may depend on active use of some data card classes such as
microprocessor cards;
— the initialisation and issuing process (which begins the operating lifetime of an individual data
card, and by which the data card is prepared for the data to be subsequently communicated to it
according to this part of ISO 21549).
The following topics are therefore beyond the scope of this part of ISO 21549:
— physical or logical solutions for the practical functioning of particular types of data cards;
— how the message is processed further “downstream” of the interface between two systems;
— the form which data takes for use outside the data card, or the way in which such data are visibly
represented on the data card or elsewhere.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 21549-1, Health informatics — Patient healthcard data — Part 1: General structure
ISO 21549-2, Health informatics — Patient healthcard data — Part 2: Common objects
© ISO 2014 – All rights reserved 1

---------------------- Page: 15 ----------------------

SIST EN ISO 21549-3:2014
ISO 21549-3:2014(E)

3 Terms and definitions
For the purposes of this document the terms and definitions given in ISO 21549-1 and ISO 21549-2 and
the following apply:
3.1
confidentiality
property that information is not made available or disclosed to unauthorized individuals, entities or
processes
[SOURCE: ISO 7498-2:1989, definition 3.3.16]
3.2
data origin authentication
corroboration that the source of data received is as claimed
[SOURCE: ISO 7498-2:1989, definition 3.3.22]
3.3
linkage
ability to join together two or more entities or parts. It may be physical, electrical or relational
4 Symbols and abbreviated terms
ASN.1 Abstract Syntax Notation version 1
HCP healthcare person
UML Unified Modelling Language
UTC Universal Time Coordinated
5 Basic data object model for a healthcare data card - Patient healthcard data
object structure
A set of basic data objects have been designed to facilitate the storage of clinical data in a flexible stru
...